Hand and finger lacerations have been estimated to have an annual incidence as high as 6,946,000 in the Unites States.
Tendon injuries often occur with hand lacerations. Additionally, tendon ruptures can also occur when there is no laceration. These are most commonly due to rheumatoid arthritis or post fracture attritional rupture. Inadvertent laceration during surgery can also occur. The management of these injuries continue to challenge the most experienced of surgeons, and this is particularly bothersome, as it has been shown that sutures placed in the dorsal half of tendons create a stronger repair than the traditional way that sutures are placed in the palmer side. Over the past 20 years or so, a considerable amount of research has been conducted on understanding the anatomy, healing properties, biomechanical forces, the strengths of various repairs and rehabilitation programs post repair of flexor and extensor tendon injuries.
Ochiai et al..sup.1 detailed the vascular anatomy of the flexor tendons and postulated the import of the vincula and dorsally located central vascular supply. Through multiple animal and invitro studies G. Lundborg.sup.2, and R. Gelberman et al..sup.3 have shown that flexor tendons have an intrinsic capacity for healing that does not require a vascular supply to the tendon itself. Their studies show that most of the tendon's nutrition comes by diffusion via the synovial fluid. FNT .sup.1.N. Ochiai et al.: Vascular Anatomy of Flexor Tendons JHS 4:321, 1979. FNT .sup.2.G. Lundborg: Experimental intrinsic healing of flexor tendons based upon synovial fluid nutrition. JHS 3:21-31, 1978. FNT .sup.3.Gelberman, R. et al.: Tendon, in Woo SLY, Buckwalter JA (eds): Injury and Repair of the Musculoskeletal Soft Tissues. Park Ridge, Ill: AAOS, 1988, pp5-40.
Gelberman et al. has also shown that the tensile strength and gliding ability of a tendon repair is enhanced with mobilization and that the more the excursion and the frequency of the motion of the tendon, the better the final outcome. This information has given rise to various passive and limited active motion rehabilitation protocols which emphasize motion of the repaired flexor tendon.
Accordingly, the current belief is that if a repair could be achieved that would allow early active flexion and extension, this would give the best functional results. Also, it is believed, that, if repair is achieved that would allow early active flexion and extension, this would further decrease the need for close occupational therapy supervision and the need for special complex and costly splints.
At the National Hand Center in Baltimore, Maryland Union Memorial Hospital, the current estimated cost of rehabilitation for a single digit flexor tendon laceration ranges between about $2,900.00 and $3,100.00 dollars per person.
U.S. Pat. No. 4,519,392 discloses hemostasing muscle clips for needleless surgery comprising two opposing toothed jaws, a hinge connecting the jaws and an open end with a locking means. A combination of two hemostasing muscle clips connected by suture material is used in strabismus surgery, thereby eliminating the need for suture and needle.
R. Savage.sup.4 has shown that the in vitro strength of the repair is proportional to the number of sutures crossing the repair site. His complex six stranded technique was three times as strong as the two stranded technique. However, these complicated multi-strand techniques are extremely bulky, technically difficult to perform and potentially damaging to the tendon and the vascular supply of the tendon. FNT .sup.4.R. Savage: In Vitro Studies of a new method of Flexor Tendon Repair. JHS (B) 1985,:10:135-141
Currently, none of the multitude of suturing techniques are sufficiently strong enough to allow for active range of motion throughout the healing process.
Therefore, there is a need extant in the art of tendon repair techniques, to provide apparatus and techniques for achieving a repair that enables early active ranges of motion of the tendons.